Mechanical impotence treatment apparatus

ABSTRACT

A male sexual impotence treatment apparatus comprises an adjustable non-inflatable restriction device ( 434 ) implanted in a male impotent patient. The restriction device directly engages a portion of the normal penile tissue of the patient, such as both of the corpora cavernosa as a single unit or one or more of the exit veins from the penis, to affect the blood flow leaving the penis. An adjustment device ( 436 ) mechanically adjusts the restriction device to temporarily restrict the blood flow leaving the penis when the patient wishes to achieve erection.

This application is a continuation of U.S. application Ser. No.10/203,086, filed Oct. 24, 2002, now allowed, which is the U.S. NationalPhase of International Application PCT/SE01/00271, filed Feb. 9, 2001,which designated the U.S., which claims the benefit of U.S. ProvisionalApplication No. 60/181,552, filed Feb. 10, 2000, the entire contents ofwhich are hereby incorporated by reference in this application.

The present invention relates to a male sexual impotence treatmentapparatus, comprising an adjustable restriction device implantable in amale patient, who suffers from sexual impotence, for directly engaging aportion of the normal penile tissue or the prolongation thereof of thepatient, and an operable adjustment device implantable in the patientfor adjusting the restriction device to temporarily contract saidportion of the normal penile tissue or the prolongation thereof torestrict the blood flow leaving the penis, when the patient desires toachieve erection.

Male sexual impotence is a widespread problem. Many different solutionsto this problem have been tried. A main solution currently practised anddisclosed in for instance U.S. Pat. Nos. 5,437,605 and 4,841,461 is toimplant a hydraulic inflatable/contractible silicon prosthesis in thecavities of the corpora cavernosa of the patient's penis. In fluidconnection with this prosthesis is a reservoir implanted in the scrotum.By manual pumping action the prosthesis is filled with fluid from thereservoir to effect erect condition or is emptied of fluid, whichreturns to the reservoir, to effect flaccid condition.

However, there are several more or less severe disadvantages of thismain solution. Above all, the penis is more or less damaged by theoperation and it is practically impossible to reverse the operation.Another disadvantage is that rather strong forces act against thisimplanted prosthesis resulting in a significant risk of the prosthesisbeing broken. A further disadvantage is that hard fibrosis createdaround the reservoir over time may cause malfunction of pumpingcomponents. Thus, the created fibrosis will sooner or later become ahard fibrotic layer which may make it difficult to pump the reservoir.Yet a further disadvantage is that the use of hydraulic fluid alwaysentails a risk of fluid leaking from the prosthesis. Furthermore, it isa rather complicated task to manually pump the reservoir when erectionis desired.

Another solution to achieve erection is to restrict the blood flowleaving the penis. For example, U.S. Pat. No. 4,829,990 discloses twohydraulically operated inflatable cuffs wrapped around the respectivecrura. Again, a disadvantage of such a solution is that it entails arisk of hydraulic fluid leaking from the cuffs.

Another example of the solution to restrict the penile blood flow isfound in U.S. Pat. No. 4,828,544, which discloses an artificial fistulasystem surgically implanted and providing a primary fistula between thefemoral artery and the femoral vein and a secondary fistula for leadingblood from the primary fistula to the penis. An inflatable balloonengages the primary fistula between the secondary fistula and the vein.The balloon is in fluid connection with a manually compressiblereservoir implanted in the scrotum. Besides the risk of fluid leakingfrom the balloon, a further disadvantage of this latter example is thatit requires delicate surgery.

A main disadvantage of the solution to restrict the penile blood flow isthe fact that the venous blood vessel system is rather complex and it isdifficult to restrict the veinplexa.

Yet another solution is to inject a substance in the vein system toachieve erection. However, injections are painful and complicated forthe patient.

The prime object of the present invention is to provide a male sexualimpotence treatment apparatus in which the risk of liquid leaking fromimplanted hydraulic components of the apparatus is substantially reducedor completely eliminated.

A further object of the invention is to provide a male sexual impotencetreatment apparatus, which does not require surgical implantation of anyfistula system.

Another object of the invention is to provide a male sexual impotencetreatment apparatus, which does not require the use of an injectionneedle.

These objects are obtained by an apparatus of the kind stated initially,which is characterised in that the adjustment device is adapted tomechanically adjust the restriction device.

The restriction device preferably is non-inflatable.

Preferably, the adjustment device adjusts the restriction device in anon-invasive manner. Furthermore, the adjustment device may adjust therestriction device in a non-manual manner and/or in a non-magneticmanner, i.e. magnetic forces may not be involved when adjusting therestriction device.

Furthermore, as opposed to prior art impotence treatment devices theadjustment device of the invention preferably is non-manually operated,i.e. not operated by manual forces or manipulated by touching the skinof the patient, such as by manually compressing a fluid containingballoon implanted in the scrotum. Instead the apparatus of the inventionmay further comprise a powered operation device for operating theadjustment device.

In the various embodiments hereinafter described the restriction devicegenerally forms an at least substantially closed loop. However, therestriction device may take a variety of different shapes, such as theshape of a square, rectangle or ellipse. The substantially closed loopcould for example be totally flat, i.e. thin as seen in the radialdirection. The shape of restriction device may also be changed duringuse, by rotation or movements of the restriction device in anydirection.

A physical lumen, such as the corpus cavernosum, crura of the peniletissue or the prolongation thereof, is often easier to restrict bycontracting at least two opposite or different side walls of the lumenagainst each other. The expression “penile tissue and the prolongationthereof” should be understood to mean the penile tissue extended insidethe human body and following the pathway of the blood flow leaving thepenis i.e. one or several exit veins from the penis, corpus cavernosum,crura or the prolongation thereof. Thus, the restriction device may bedesigned to perform such a contracting effect of the opposite walls alsoof a exit vein in the penile prolongation.

Alternatively, the restriction device may comprise an adjustable cuff, aclamp or a roller for bending the vein, corpus cavernosum, crura or theprolongation thereof to restrict the blood flow therein. Such a cuff,clamp or roller may also be utilised for squeezing the vein, corpuscavernosum, crura or the prolongation thereof against human materialinside the body of the patient or against implanted structures of theapparatus.

Preferably, the restriction device comprises an elongated restrictionmember and forming means for forming the restriction member into atleast a substantially closed loop around said portion of the tissue,wherein the loop defines a restriction opening, whereby the adjustmentdevice adjusts the restriction member in the loop to change the size ofthe restriction opening.

The restriction device may be implanted in the base of the patient'spenis or the prolongation thereof and preferably may engage the corpuscavernosum, crura or the prolongation thereof of the penis. However,there are several alternative positions of the restriction device thatgive more or less satisfactory restriction of the blood flow leaving thepenis. Thus, as a first alternative the restriction member may extendaround both corpora cavernosa or crura of the penis as a single unit. Asa second alternative the restriction device may comprise two elongatedrestriction members extending around respective corpora cavernosa orcrura of the patient. As a third alternative the elongated restrictionmember may encircle one of the exit veins from the penis. As a fourthalternative the restriction device may comprise several restrictionmembers extending around respective exit veins from the penis.

The adjustment device may be incorporated in the restriction device aswell as be controlled by hydraulic means.

In accordance with a preferred first adjustment principle, theadjustment device mechanically adjusts the longitudinal extension of theelongated restriction member in a loop form.

In a preferred embodiment of the invention utilising the firstadjustment principle, the restriction member comprises a main portionand two elongated end portions, and the adjustment device establisheslongitudinal relative displacement between the end portions of therestriction member, so that the size of the restriction opening isadjusted. The forming means may comprise any suitable known orconventional device capable of practising the desired function, such asa spring material forming the elongated restriction member into theloop, so that the restriction opening has a predetermined size, and theadjustment device may adjust the restriction member against the springaction of the spring material. In other words, the restriction membermay comprise a spring clip. The spring material may be integrated in therestriction member.

Preferably, the adjustment device comprises a movement transferringmember, suitably a drive wheel, in engagement with at least one of theend portions of the restriction member and operable to displace the oneend portion relative to the other end portion of the restriction member.The drive wheel may advantageously be in engagement with both of the endportions of the restriction member and be operable to displace said endportions relative to each other. An elongated flexible drive shaft maybe operatively connected to the drive wheel, for transferring manual ormotor generated power from a location remote from the restrictionmember. In its simplest embodiment, the drive wheel may comprise apulley in frictional engagement with the restriction member. As analternative, a gear rack may be formed on at least one of the endportions of the restriction member and the drive wheel may comprise agear wheel in mesh with the gear rack. Other suitable known orconventional mechanisms may also or alternatively be used as theadjustment device.

The movement transferring member may alternatively comprise at least onecylinder and a piston, which is movable therein and is connected to oneof the end portions of the restriction member, the piston being operableto longitudinally displace the one end portion of the restriction memberrelative to the other end portion of the restriction member.Alternatively, the movement transferring means may comprise twointerconnected cylinders and two pistons in the respective cylindersconnected to said end portions, respectively, of the restriction member,the pistons being operable to longitudinally displace the end portionsof the restriction member relative to each other. Other known orconventional devices also or alternatively can be used as the movementtransferring member.

A motor, which is fixed relative to the main portion of the restrictionmember and has a rotating drive shaft operatively connected to themovement transferring member, may be positioned relative to theelongated restriction member such that the drive shaft extendstransverse thereto. Alternatively, the motor may be positioned relativeto the elongated restriction member such that the drive shaft extendssubstantially tangentially to the loop of the restriction member.

In another embodiment of the invention utilizing the first adjustmentprinciple, the elongated restriction member is longitudinally resilientand the adjustment device comprises a contraction device forlongitudinally contracting the resilient restriction member. Preferably,the elongated restriction member comprises a substantially non-resilientmain portion and an end portion forming an elongated helical spring,which is contractible by the contraction device. The contraction devicemay suitably comprise an elongated flexible pulling member connected tothe main portion of the restriction member and extending through thehelical spring to contract the helical spring against an arrestingmember, which is fixed relative to the main portion of the restrictionmember. The pulling member may extend in an elongated tube joined at oneend thereof to the arresting member, so that a motor remote from therestriction member may be attached to the other end of the elongatedtube and pulls the pulling member through the tube to contract thehelical spring.

In yet another embodiment of the invention utilizing the firstadjustment principle, the elongated restriction member comprises anelongated helical spring having a free end, and a body to which thespring is nonrotatably secured at its opposite end. The adjustmentdevice rotates the helical spring in one direction to enlarge the coilsof the helical spring to longitudinally contract the spring and torotate the spring in the opposite direction to reduce the size of thecoils of the spring to longitudinally extend the spring. As a preferredalternative, the restriction member comprises a further elongatedhelical spring having a free end and nonrotatably secured to the body atits opposite end, and the adjustment device comprises a drive shafthaving two opposite end portions connected to the springs, respectively,at their free ends, the helical coils forming left and right handhelices, respectively. The adjustment device may alternatively comprisea gearing having an input shaft and two opposite aligned output shaftsconnected to the helical springs, respectively, at their free ends, theinput shaft being connected to said output shafts so that the outputshafts rotate in the opposite directions upon rotation of the inputshaft, the helical coils forming the same helices.

In accordance with a second adjustment principle, the adjustment devicemechanically adjusts the restriction member so that at least a portionof a radially innermost circumferential confinement surface formed bythe restriction member is substantially radially displaced.

In one embodiment of the invention utilizing the second adjustmentprinciple, the restriction member comprises an elongated voltageresponsive element forming part of the confinement surface and capableof bending into a bow in response to a voltage applied across theelement, the radius of curvature of the bow being adjustable by changingthe level of the voltage.

In another embodiment of the invention utilizing the second adjustmentprinciple, the adjustment device changes the diameter of an elasticannular element of the restriction member, which forms the confinementsurface. Preferably, the forming means comprises a substantially rigidouter annular element coaxially surrounding the elastic annular element,and the adjustment device comprises means for pulling the elasticannular element radially outwardly towards the outer annular element toexpand the elastic annular element. For example, the pulling means maycomprise a plurality of threads secured to the elastic annular elementalong the circumference thereof and running from the elastic annularelement via guide members attached to the outer annular element.

In yet another embodiment of the invention utilizing the secondadjustment principle, the forming means comprises a substantially rigidouter annular element, and the restriction member comprises an elongatedhelical spring extending internally along the outer annular element andcontacting the latter. The helical spring forms part of thecircumferential confinement surface and has a free end. The restrictionmember further comprises a body to which the spring is nonrotatablysecured at its opposite end. The adjustment device rotates the helicalspring in one direction to enlarge the coils of the spring to contractthe circumferential confinement surface and rotates the spring in theopposite direction to reduce the size of the coils of the spring toexpand the circumferential confinement surface. As an alternative, whichis preferred, the restriction member comprises two elongated helicalsprings forming part of the circumferential confinement surface andconnected to the body of the restriction member. The adjustment devicerotates each spring in one direction to enlarge the coils of the springto contract the circumferential confinement surface and rotates thespring in the opposite direction to reduce the size of the coils of thespring to expand the circumferential confinement surface.

In accordance with a third adjustment principle, the restriction membercomprises at least two separate elements, at least one of which ispivoted so that it may turn in a plane in which the restriction memberextends, and the adjustment device turns the pivoted element to changethe size of the restriction opening. Preferably, the restriction membercomprises a plurality of separate pivoted elements disposed in series,each pivoted element being turnable in the plane, and the adjustmentdevice turns all of the pivoted elements to change the size of therestriction opening. For example, the pivoted elements may compriselamellae arranged like the conventional adjustable aperture mechanism ofa camera.

In accordance with a fourth adjustment principle, the adjustment devicefolds at least two foldable frame elements of the restriction membertowards each other. Preferably, the foldable frame elements comprise twosubstantially or partly semi-circular frame elements which are hingedtogether so that the semi-circular elements are swingable relative toeach other from a fully open state in which they form part of a circleto a fully folded state in which they form part of a semi-circle. Thesame principal may be used with the swingable parts mounted together inone end and not in the other end. Alternatively, the restriction devicemay comprises two preferable rigid articulated clamping elementspositioned on opposite sides of a vein like the blades of a scissor, andthe adjustment device turns the clamping elements toward each other toclamp the vein, corpus cavernosum, crura or the prolongation thereofbetween the clamping elements, thereby restricting the blood flow in thevein, corpus cavernosum, crura or the prolongation thereof.

In accordance with a fifth adjustment principle, the adjustment deviceturns the restriction member around a longitudinal extension thereof,the elongated restriction member being elastic and varying in thicknessas seen in a cross-section therethrough. Suitably, the elongatedrestriction member comprises an elastic belt.

In accordance with a sixth adjustment principle, the adjustment devicechanges the size of the restriction opening such that the outercircumferential confinement surface of the restriction member ischanged.

In accordance with a seventh adjustment principle, the adjustment devicechanges the size of the restriction opening such that the outercircumferential confinement surface of the restriction member isunchanged.

In accordance with an eighth adjustment principle, the elongatedrestriction member may be flexible, and the adjustment device pulls afirst portion of the flexible restriction member from a second portionof the flexible restriction member opposite the first portion in theloop to squeeze a vein, the corpus cavernosum, the crura or theprolongation thereof between two opposite lengths of the elongatedflexible restriction member to restrict the blood flow in the vein,corpus cavernosum, crura or the prolongation thereof.

In accordance with a ninth adjustment principle, the restriction devicecomprises two rigid elements on opposite or different sides of a vein,the corpus cavernosum, the crura or the prolongation thereof, and theadjustment device decreases the distance between the rigid elements tosqueeze the vein, corpus cavernosum, crura or the prolongation thereofbetween the rigid elements, thereby restricting the blood flow in thevein, corpus cavernosum, crura or the prolongation thereof.

In accordance with a tenth adjustment principle, the restriction devicebends or rotates a portion of a vein, the corpus cavernosum, the cruraor the prolongation thereof to restrict the blood flow in the same. Forexample, the restriction device may comprise at least two bendingmembers, such as cylindrical or hour-glass shaped rollers, positioned onopposite or different sides of the vein and displaced relative to eachother along the vein, corpus cavernosum, crura or the prolongationthereof, and the adjustment device may move the bending members againstthe vein, corpus cavernosum, crura or the prolongation thereof to bendthe latter to restrict the blood flow in the vein, corpus cavernosum,crura or the prolongation thereof. Suitably, the displacement membersmay comprise rollers. The restriction device may also rotate a portionof the esophagus or stomach. The bending or rotating members may takeany shape. With the prolongation of the corpus cavernosum or crurashould be understood the penile tissue extended inside the human bodyand following the pathway of the blood flow leaving the penis.

Alternatively, the two bending members one placed more distal than theother may be rotated in opposite direction relative to each other. Withinterconnecting material for example flexible bands between the holdingmembers a restriction will occur between the bending members when theyare rotated.

The restriction device may in all applicable embodiments take any shapeand be either hydraulic or non-inflatable.

In all of the above-described embodiments of the invention theadjustment device is conveniently operated by any suitable motor,preferably an electric motor, which may be fixed directly to or beplaced in association with the restriction device, or alternatively belocated remote from the restriction device, advantageously in theabdomen or subcutaneously. In the latter alternative the motor isadvantageously connected to the adjustment device by a flexible powertransmission conduit to permit a suitable positioning of the motor inthe abdomen of the patient. The motor may be manually activatable, forexample by an implanted switch.

In some of the above described embodiments of the invention, however,the adjustment device may conveniently be operable by a hydraulicoperation device, which preferably is manually activatable. Thehydraulic operation device may advantageously include hydraulic servomeans to facilitate manual activation. As an alternative, the hydraulicdevice may be powered by an electric motor, which may be manuallyactivatable or controlled by remote control means. The components ofsuch a hydraulic operation device may be placed in association with therestriction device and/or be located at a suitable place in the abdomenor subcutaneously.

More specifically, a reservoir may be provided containing apredetermined amount of fluid for supplying the hydraulic operationdevice with fluid. The reservoir defines a chamber for the predeterminedamount of fluid and the hydraulic operation device changes the size ofthe chamber. The hydraulic operation device may comprise first andsecond wall portions of the reservoir, which are displaceable relativeto each other to change the size of the chamber of the reservoir. Thefirst and second wall portions of the reservoir may be designed to bedisplaceable relative to each other by manual manipulation thereof,preferably to permit manual pushing, pulling or rotation of any of thewall portions in one direction. Alternatively, the wall portions may bedisplaceable relative to each other by magnetic means (such as apermanent magnet and magnetic material reed switch, or other known orconventional magnetic devices), hydraulic means or electrical controlmeans such as an electric motor. The magnetic means, hydraulic means, orelectrical control means may all be activated by manual manipulation,preferably using a subcutaneously located manually manipulatable device.This control may be indirect, for example via a switch.

The hydraulic operation device may operate the adjustment device withfluid from the reservoir in response to a predetermined firstdisplacement of the first wall portion of the reservoir relative to thesecond wall portion of the reservoir, to adjust the restriction deviceto release the tissue, and to operate the adjustment device with fluidfrom the reservoir in response to a predetermined second displacement ofthe first wall portion of the reservoir relative to the second wallportion of the reservoir, to adjust the restriction device to restrictthe blood flow leaving the penis. In this embodiment, no pump is used,only the volume of the reservoir is varied. This is of great advantagecompared to the solution described below when a pump is used to pumpfluid between the reservoir and the adjustment device because there isno need for a non-return valve and it is still possible to have fluidgoing both to and from the reservoir.

As an alternative, the hydraulic operation device may comprise a pumpfor pumping fluid between the reservoir and the adjustment device. Thepump may pump fluid both to and away from the adjustment device, orhydraulic means controlling the adjustment device. A mechanical manualsolution is proposed in which it is possible to pump in both directionsjust by pushing an activating member in one direction. Anotheralternative is a pump pumping in only one direction and an adjustablevalve to change the direction of fluid to either increase of decreasethe amount of fluid in the reservoir. This valve may be manipulatedmanually, mechanically, electrically, magnetically, or hydraulically.Any kind of motor could of course be used for all the differentoperations as well as wireless remote solutions. The pump may comprise afirst activation member for activating the pump to pump fluid from thereservoir to the adjustment device and a second activation member foractivating the pump to pump fluid from the adjustment device to thereservoir. The activation members may be operable by manualmanipulation, preferably to permit manual pushing, pulling or rotatingthereof in one direction. Suitably, at least one of the activationmembers is adapted to operate when subjected to an external pressureexceeding a predetermined magnitude.

Alternatively, at least one of the first and second activating membersmay be operable by magnetic means, hydraulic means or electrical controlmeans such as an electric motor. The magnetic means, hydraulic means, orelectrical control means may all be activated by manual manipulatingmeans preferably located subcutaneously. This activation may beindirect, for example via a switch.

Advantageously, especially when manual manipulation means are used, aservo means could be used. With servo means less force is needed foroperating the adjustment device. The term “servo means” encompasses thenormal definition of a servo mechanism, i.e. an automatic device thatcontrols large amounts of power by means of very small amounts of power,but may alternatively or additionally encompass the definition of amechanism that transfers a weak force acting on a moving element havinga long stroke into a strong force acting on another moving elementhaving a short stroke. The servo means may comprise a motor, preferablyan electric motor, which may be reversible.

Alternatively, a reverse servo may be employed. The term “reverse servo”is to be understood as a mechanism that transfers a strong force actingon a moving element having a short stroke into a weak force acting onanother moving element having a long stroke; i.e. the opposite functionof the above-defined alternative mechanism of a normal servo mechanism.A first closed hydraulic system that controls another closed hydraulicsystem in which hydraulic means of the adjustment device is incorporatedmay be used. Minor changes in the amount of fluid in a smaller reservoirof the first system could then be transferred by the reverse servo intomajor changes in the amount of fluid in a larger reservoir in the secondsystem. In consequence, the change of volume in the larger reservoir ofthe second system will affect the hydraulic means of the adjustmentdevice. For example, a short stroke that decreases the volume of thesmaller reservoir will cause the larger reservoir to supply theadjustment device with a large amount of hydraulic fluid, which in turnresults in a long mechanical adjustment stroke on the restrictiondevice. The great advantage of using such a reverse servo is that thelarger volume system could be placed inside the abdomen orretroperitoneum where there is more space and still it would be possibleto use manual manipulation means of the smaller system subcutaneously.The smaller reservoir could be controlled directly or indirectly by afluid supply means. The fluid supply means may include another smallreservoir, which may be placed subcutaneously and may be activated bymanual manipulation means. Both the servo and reverse servo may be usedin connection with all of the various components and solutions describedin the present specification.

Preferably, the reverse servo comprises hydraulic means and a main fluidsupply reservoir and eventually an additional fluid supply reservoir.Both reservoirs define a chamber containing hydraulic fluid, and thehydraulic means comprises first and second wall portions of the mainfluid supply reservoir, which are displaceable relative to each other tochange the volume of the chamber of the main fluid supply reservoir. Thehydraulic means may control the adjustment device indirectly, e.g. viaan increased amount of fluid in the main fluid supply reservoir, inresponse to a predetermined first displacement of the first wall portionof any of the reservoirs relative to the second wall portion of thereservoir to restrict the blood flow leaving the penis, and to controlthe adjustment device in response to a second displacement of the firstwall portion of any reservoir relative to the second wall portion, toindirectly adjust the restriction device to release the penile tissue.The wall portions of the reservoirs may be designed to be displaceablerelative to each other by manual manipulation thereof or be displaceablerelative to each other by manually pushing, pulling or rotating any ofthe wall portions of the reservoir in one direction. Alternatively, thewall portions of the main fluid supply reservoir may be displaceablerelative to each other by magnetic means, hydraulic means or electriccontrol means including an electric motor.

The magnetic means, hydraulic means, or electrical control means may allbe activated by manually manipulated means preferably locatedsubcutaneously. This control may be indirect for example via a switch.

Even in the broadest embodiment of the invention the adjustment devicemay comprise a servo means. The servo means may comprise a hydraulicoperation means, an electrical control means, a magnetic means,mechanical means or a manual manipulation means. The hydraulic operationmeans, electrical control means, mechanical means or magnetic means maybe activated by manual manipulating means. Using a servo system willsave the use of force when adjusting the adjustment device which may beof importance in many applications, for example when a battery cannotput out enough current although the total energy in the battery is morethan enough to power the system.

In accordance with a preferred embodiment of the invention, theapparatus comprises implantable electrical components including at leastone, or only one single voltage level guard and a capacitor oraccumulator, wherein the charge and discharge of the capacitor oraccumulator is controlled by use of the voltage level guard. As aresult, there is no need for any implanted current detector and/orcharge level detector for the control of the capacitor, which makes theapparatus simple and reliable.

All solutions may be controlled by a wireless remote control forcontrolling the adjustment device. The remote control may advantageouslybe capable of obtaining information related to the blood flow leavingthe penis or the blood pressure or other important physical parametersand of commanding the adjustment device to adjust the restriction devicein response to obtained information. With the wireless remote controlthe apparatus of the invention is conveniently controlled by the patientwhen he so desires, which is of great advantage compared to the priorart procedures. With the remote control the apparatus of the inventionis conveniently controlled to adjust the implanted restriction device,which controls the blood flow leaving the penis. The restriction devicemay be operable to open and close the blood flow passageway formed bythe penile exit veins. The restriction device may steplessly control thecross-sectional area of the passageway.

The apparatus may further comprise a pressure sensor for directly orindirectly sensing the pressure against the restriction device and therestriction device may control the blood flow in response to signalsfrom the pressure sensor. The pressure sensor may be any suitable knownor conventional pressure sensor such as shown in U.S. Pat. No.5,540,731, 4,846,181, 4,738,267, 4,571,749, 4,407,296 or 3,939,823; oran NPC-102 Medical Angioplasty Sensor. The adjustment device preferablynon-invasively adjusts the restriction device to change the size of thecross-sectional area.

The adjustment device and/or other energy consuming components of theapparatus may be energised with wirelessly transmitted energy fromoutside the patient's body or be powered by an implanted battery oraccumulator.

The apparatus may further comprise an implanted energy transformingdevice for transforming wireless energy directly or indirectly intokinetic energy for operation of the restriction device. The energytransforming device may, preferably directly, transform the wirelessenergy in the form of sound waves into electric energy for operation ofthe restriction device. Suitably the energy transforming devicecomprises a capacitor adapted to produce electric pulses from thetransformed electric energy.

The apparatus of the invention may further comprise an energy transfermeans for wireless transfer of energy from outside the patient's body tothe adjustment device and/or other energy consuming implantablecomponents of the apparatus. The energy transfer means may be adapted tointermittently transfer the energy, preferably electric energy, in theform of a train of energy pulses for direct use in connection with theenergising of the energy consuming components of the apparatus. Animplanted capacitor having a capacity less than 0.1 μF may be used forproducing the train of energy pulses.

A motor may be implanted for operating the adjustment device, whereinthe energy transfer means is adapted to directly power the motor withtransferred energy. Alternatively, or in combination with the motor, apump may be implanted for operating the adjustment device, wherein theenergy transfer means is adapted to transfer wireless energy in the formof electromagnetic waves for direct power of the pump. Preferably, thepump is not a plunger type of pump, but may comprise a peristaltic ormembrane pump.

The energy transfer means preferably transfers wireless energy in theform of electromagnetic waves. However, for safety radio waves may beexcluded.

Alternatively, the energy transferred by the energy transfer means maycomprise an electric field or a magnetic field.

Most preferred, the energy transferred by the energy transfer meanscomprises a signal.

Preferably, the wireless remote control comprises a separate signaltransmitter or receiver and a signal receiver or transmitter implantedin the patient. For example, the signal transmitter and signal receivermay transmit and receive a signal in the form of digital pulses, whichmay comprise a magnetic or electric field. Alternatively, which ispreferred, the signal transmitter and signal receiver may transmit andreceive an electromagnetic wave signal, a sound wave signal or a carrierwave signal for a remote control signal. The receiver may comprise animplanted control unit for controlling the adjustment device in responseto a control signal from the signal transmitter.

The apparatus of the invention may further comprise an implantedenergiser unit for providing energy to energy consuming implantedcomponents of the apparatus, such as electronic circuits and/or a motorfor operating the adjustment device. The apparatus may comprise anexternal energy transmitter for transmitting wireless energy, whereinthe energiser unit is adapted to transform the wireless energy intoelectric energy. An implanted electric motor may operate the adjustmentdevice and the energiser unit may be adapted to power the electric motorwith the electric energy transformed from the wireless energy.

The energiser unit may comprise a battery and a switch operable by thewireless energy transmitted by the external transmitter, for connectingthe battery to the implanted energy consuming components of theapparatus in an “on” mode when the switch is powered by the wirelessenergy and to keep the battery disconnected from the energy consumingcomponents in a “standby” mode when the switch is not powered.

The control unit may power such an implanted motor with energy providedby the energiser unit in response to a control signal received from thesignal transmitter. Any known or conventional signal transmitter orsignal receiver that is suitable for use with a human or mammal patientmay be provided as the signal transmitter or signal receiver of theinvention.

Generally, all the signals mentioned above may comprise electromagneticwaves, such as infrared light, visible light, laser light, micro waves,or sound waves, such as ultrasonic waves or infrasonic waves, or anyother type of wave signals. The signals may also comprise electric ormagnetic fields, or pulses. All of the above-mentioned signals maycomprise digital signals. The control signals may be carried by acarrier wave signal, which in an alternative embodiment may be the samesignal as the wireless energy signal. Preferably a digital controlsignal may be carried by an electromagnetic wave signal. The carrierwave or control signal may be amplitude or frequency modulated.

The motor may be any type of motor, such as a pneumatic, hydraulic orelectric motor and the energiser unit may power the motor withpressurized gas or liquid, or electric energy, depending on the type ofmotor. Where the motor is an electric motor, it may power pneumatic orhydraulic equipment.

The energiser unit may comprise a power supply and the control unit maypower the motor with energy from the power supply. Preferably, the powersupply is an electric power supply, such as a battery, and the motor isan electric motor. In this case, the battery also continuously powers atleast part of the circuitry of the signal receiver in a standby modebetween the adjustments, in order to keep the signal receiver preparedfor receiving signals transmitted from the signal transmitter.

The energiser unit may transfer energy from the control signal, as thecontrol signal is transmitted to the signal receiver, into electricenergy for powering the implanted electronic components. For example,the energiser unit may transfer the energy from the control signal intoa direct or alternating current.

In case there is an implanted electric motor for operating theadjustment device the energiser unit may also power the motor with thetransferred energy. Advantageously, the control unit directly powers theelectric motor with electric energy, as the energiser unit transfers thesignal energy into the electric energy. This embodiment is particularlysimple and does not require any recurrent invasive measures forexchanging empty power supplies, such as batteries, that is required inthe first embodiment described above. The motor may also be directlypowered with wirelessly transmitted electromagnetic or magnetic energyin the form of signals, as the energy is transmitted. All the variousfunctions of the motor and associated components described in thepresent specification may be used where applicable.

For adjustment devices of the type that requires more, but stillrelatively low, power for its operation, the energiser unit may comprisea rechargeable electric power supply for storing the electric energyobtained and the control unit may power the electric motor with energyfrom the rechargeable electric power supply in response to a controlsignal received from the signal transmitter. In this case, therechargeable power supply can be charged over a relatively long time(e.g. a few seconds up to a half hour) without powering the electricmotor.

The electric power supply suitably comprises an inexpensive simplecapacitor. In this case, the electric motor may be a stepping motor. Inall embodiments the motor may preferable be able to perform a reversingfunction.

The signal transmitter may transmit an electromagnetic signal and theenergiser unit may draw radiant energy from the electromagnetic wavesignal, as the latter is transmitted to the signal receiver, andtransfer the radiant energy into electric energy.

Alternatively, the energiser unit may comprise a battery or accumulator,an electrically operable switch adapted to connect the battery to thesignal receiver in an on mode when the switch is powered and to keep thebattery disconnected from the signal receiver in a standby mode when theswitch is not powered, and a rechargeable electric power supply forpowering the switch. The control unit may power the electric motor withenergy from the battery in response to a control signal received fromthe signal transmitter, when the switch is in its on mode.Advantageously, the energiser unit may transform wave energy from thecontrol signal, as the latter is transmitted to the signal receiver,into a current for charging the rechargeable electric power supply,which suitably is a capacitor. Energy from the power supply is then usedto change the switch from off (standby mode) to on. This embodiment issuited for adjustment devices of the type that require relatively highpower for their operation and has the advantage that the electroniccircuitry of the signal receiver does not have to be powered by thebattery between adjustments. As a result, the lifetime of the batterycan be significantly prolonged. The switch may be switched manually orby the use of magnetic or electric energy.

As an example, the signal transmitter may transmit an electromagneticwave signal and the energiser unit may draw radiant energy from theelectromagnetic wave signal, as the latter is transmitted to the signalreceiver, and may transfer the radiant energy into said current. Theenergiser unit suitably comprises a coil of the signal receiver forinducing an alternating current as the electromagnetic wave signal istransmitted through the coil and a rectifier for rectifying thealternating current. The rectified current is used for charging therechargeable power source.

Alternatively, the signal transmitter and receiver may solely be usedfor a control signal and a further pair of signal transmitter andreceiver may be provided for transferring signal energy to implantedcomponents. By such a double system of signal transmitters and receiversthe advantage is obtained that the two systems can be designed optimallyfor their respective purposes, namely to transmit a control signal andto transfer energy from an energy signal. Accordingly, the apparatus mayfurther comprise an external energy transmitter for transmittingwireless energy, wherein the energiser unit comprises a battery and anoperable switch for connecting the battery to the signal receiver in an“on” mode when the switch is powered and for keeping the batterydisconnected from the signal receiver in a “standby” mode when theswitch is not powered, and the external energy transmitter powers theswitch. Suitably, the energy transmitter may directly power the switchwith the wireless energy to switch into the “on” mode. As should berealized by a skilled person, in many of the above-described embodimentsof the invention the adjustment device may be operated by control meansor manual manipulation means implanted under the skin of the patient,such as a pump, an electrical switch or a mechanical movementtransferring means. In the manual embodiment it is not necessary to usea motor for operating the adjustment device.

In embodiments including hydraulic transmission means, an injection portconnected to the hydraulic means may be provided for enabling, normallysingle, once-and-for-all, calibration of the amount of fluid in thehydraulic system.

In all embodiments a motor may be operatively connected to theadjustment device. A reversing device may be implanted in the patientfor reversing the motor. The adjustment device preferably adjusts therestriction device in a non-manual manner without the patient touchinghis skin.

The adjustment device may be adapted to hydraulically adjust therestriction device by using hydraulic means which is devoid of hydraulicfluid of the kind having a viscosity that substantially increases whenexposed to heat or a magnetic field, i.e. the hydraulic fluid would notbecome more viscous when exposed to heat or influenced by magneticforces.

All the above-described various components, such as the motor, pump andcapacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable.

All the various ways of transferring energy and controlling the energypresented in the present specification may be practised by using all ofthe various components and solutions described.

The invention also provides a method for treating male sexual impotence,comprising surgically implanting in the body of a male patient sufferingfrom sexual impotence an adjustable restriction device which directlyengages a portion of the normal penile tissue of the patient to affectthe blood flow leaving the penis and the prolongation thereof, and whendesired to achieve erection, mechanically adjusting the restrictiondevice to temporarily restrict the blood flow leaving the penis.

The method may further comprise implanting the male sexual impotencetreatment apparatus in the base of the patient's penis or itsprolongation, preferably implanting an restriction device engaging thecorpora cavernosa, crura or the prolongation thereof as a single unit orengaging the two corpora cavernosa or crura or the prolongations thereofseparately. The method may comprise implanting the restriction deviceengaging one or both of the crura of the penis.

As a modification, the method may further comprise implanting therestriction device engaging at least one of the exit veins from thepenis.

The invention provides another method for treating male sexualimpotence, comprising the steps of: placing at least two laparascopicaltrocars in the body of a male patient suffering from sexual impotence,inserting a dissecting tool through the trocars and dissecting an areaof the penis and abdominal or peritoneal surroundings, placing at leastone adjustable restriction device in the dissected area engaging thepenile tissue or the prolongation thereof, and adjusting the restrictiondevice to restrict the blood flow leaving the penis when the patientwishes to achieve erection.

The method may further comprise mechanically adjusting said restrictiondevice in a non-manual manner. The restriction device may engage (a)both of the corpora cavernosa, the crura of the penis or theprolongation thereof as a single unit; or (b) one of the exit veins fromthe penis.

Alternatively, the method may further comprise implanting (a) a furtheradjustable restriction device, wherein the two restriction devicesengage the two corpora cavernosa, the crura of the penis or theirprolongations, respectively, as separate units; or (b) severalrestriction devices engaging respective exit veins from the penis.

The method may further comprise implanting a source of energy in thepatient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy to therestriction device.

The invention is described in more detail in the following withreference to the accompanying drawings, in which

FIG. 1 is a schematic sectional view of a preferred first embodiment ofthe male sexual impotence treatment apparatus in accordance with theinvention;

FIGS. 2 and 3 are cross-sectional views taken along the lines II-II andIII-III, respectively, of FIG. 1;

FIGS. 4 and 5 schematically show two alternative designs of theembodiment of FIG. 1;

FIG. 6 schematically illustrates a motor arrangement for the designaccording to FIG. 5;

FIG. 7 is a schematic sectional view of a second embodiment of theapparatus in accordance with the invention;

FIG. 8 schematically illustrates a hydraulic transmission conduit forthe embodiment of FIG. 7;

FIG. 9 is a schematic sectional view of a third embodiment of theapparatus in accordance with the invention;

FIG. 10 is a modification of the embodiment of FIG. 9;

FIG. 11 is a schematic view of a fourth embodiment of the apparatus inaccordance with the invention;

FIGS. 12 and 13 are enlarged details of the embodiment of FIG. 11;

FIG. 14 is a cross-section along the line XIV-XIV of FIG. 11;

FIG. 15 is a schematic view of a fifth embodiment of the apparatus inaccordance with the invention;

FIG. 16 is an enlarged detail of FIG. 15;

FIG. 17 is a cross-section along the line XVII-XVII of FIG. 15;

FIGS. 18 to 21 are schematic sectional views of a sixth, seventh, eighthand ninth embodiments, respectively, of the apparatus in accordance withthe invention;

FIGS. 22 and 23 illustrate a fully open and a reduced restrictionopening, respectively, of the embodiment of FIG. 21;

FIG. 24 is a schematic view of a tenth embodiment of the apparatus inaccordance with the invention;

FIG. 25 is an enlarged detail of the embodiment of FIG. 24;

FIGS. 26 and 27 illustrate a fully open and a reduced restrictionopening, respectively, of the embodiment of FIG. 24;

FIG. 28 schematically illustrates a cushion arrangement for protectingthe tissue of the patient;

FIG. 29A-D is a block diagram of four different principal embodiments ofthe invention;

FIG. 30A-D are cross-sectional views of a pump mechanism according toFIG. 29C, which pumps fluid in opposite directions by mechanicallypushing a wall portion in only one direction;

FIG. 31 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 29B or30B;

FIG. 32 is a cross-sectional view of a reservoir having a variablevolume adjustable by manual manipulation, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 29B or29D;

FIG. 33A is a front view of a hydraulic, pneumatic or mechanical reverseservo system in accordance with a particular embodiment of the principalembodiment shown in FIG. 29D;

FIG. 33B is a cross-sectional view taken along line VB-VB of FIG. 33A;

FIG. 34 is a block diagram illustrating remote control components of theapparatus of the invention;

FIG. 35 is a schematic view of a circuitry used for the system of theblock diagram of FIG. 34;

FIGS. 36A and 36B are schematic views of an eleventh embodiment of theapparatus in accordance with the invention;

FIGS. 37A and 37B are schematic views of a twelfth embodiment of theapparatus in accordance with the invention;

FIG. 38 is a schematic view of a thirteenth embodiment of the apparatusin accordance with the invention;

FIGS. 39A, 39B and 39C are a schematic front view and schematicsectional views, respectively, of a fourteenth embodiment of theapparatus in accordance with the invention;

FIGS. 40A through 44B are five modifications of the embodiment of FIGS.39A-39C;

FIG. 45 illustrates the apparatus of the invention with a restrictiondevice implanted around the corpus cavernosum of a patient; and

FIG. 46 illustrates the apparatus of the invention with two restrictionmembers implanted around respective exit veins from the penis of apatient.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIGS. 1-3 show a preferred embodiment of the male sexual impotencetreatment apparatus of the invention comprising a restriction devicehaving an elongated restriction member in the form of a circularresilient core 2 with two overlapping end portions 4,6. The core 2defines a substantially circular restriction opening and is enclosed inan elastic soft hose 8 except at a releasable and lockable joint 10 ofthe core 2, which when released enables application of the core 2 withits hose 8 around a tissue of a patient, such as the corpus cavernosumor one or more exit veins from the patient's penis. The materials of allof these elements are bio-compatible so that the patient's body will notreject them. A mechanical adjustment device 12 for mechanicallyadjusting the longitudinal extension of the core 2 to change the size ofthe restriction opening comprises a drive wheel 14 in frictionalengagement with the overlapping end portions 4,6 of the core 2. Thedrive wheel 14 is journalled on a holder 16 placed in the hose 8 andprovided with two counter pressure rollers 18,20 pressing the respectiveend portions 4, 6 of the core 2 against the drive wheel 14 to increasethe frictional engagement therebetween. An electric motor 22 isconnected to the drive wheel 14 via a long flexible drive shaft 24 andis moulded together with a remote controlled power supply unit 26 in abody 28 of silicone rubber. The length of the flexible drive shaft 34 isselected so that the body 28 can be placed in a desired position in thepatient's body, suitably in the abdomen.

When the patient wishes to achieve erection, he controls the powersupply unit 26 to power the electric motor 22 to turn the drive wheel 14in one direction to reduce the diameter of the core 2, so that thepenile tissue is squeezed and the blood flow leaving the penis isrestricted. When the patient wishes to regain flaccid condition of hispenis, he controls the power supply unit 26 to power the electric motor22 to turn the drive wheel 14 in the opposite direction to increase thediameter of the core 2, so that the tissue is released.

Alternatively, a rack gear may be formed on one of the end portions 4,6of the core 2 and the drive wheel 14 may be replaced by a drive gearwheel connected to the other end portion of the core 2 and in mesh withthe rack gear.

FIG. 4 shows an embodiment of the invention which is identical to theembodiment of FIGS. 1-3, except that the motor 22 is encapsulated in alateral protrusion 30 of the hose 8 so that it is fixed to the core 2and has a short drive shaft 32 onto which the drive wheel 14 is mounted,and that the motor 22 is positioned relative to the circular core 2 suchthat the drive shaft 32 extends radially thereto.

FIG. 5 shows an embodiment of the invention which likewise is identicalto the embodiment of FIGS. 1-3, except that the motor 22 is encapsulatedin the hose 8 so that it is fixed to the core 2 and has a short driveshaft 32, and that the motor 22 is positioned relative to the core 2such that the drive shaft 32 extends substantially tangentially to thecircular core 2. There is an angular gearing 34 connecting the driveshaft 32 to the drive wheel 14.

FIG. 6 shows a suitable arrangement for the motor 22 in the embodimentof FIG. 5, comprising a first clamping member 36 secured to one endportion of the core 2 and a second clamping member 38 secured to theother end portion 6 of the core 2. The motor 22 is secured to the firstclamping member 36 and is operatively connected to a worm 40 via a geartransmission 42. The worm 40 is journalled at its opposite ends onholders 44 and 46, which are rigidly secured to the clamping member 36and the motor 22, respectively. The second clamping member 38 has apinion in mesh with the worm 40. When the motor 22 is powered the worm40 rotates and will thereby pull the end portion 6 of the core 2 in oneor the opposite longitudinal direction, so that the diameter of thesubstantially circular core 2 is either increased or decreased.

FIG. 7 shows an embodiment of the invention in which the elongatedrestriction member comprises a core 48 and a helical spring 50. A springcontracting means in the form of a flexible pulling member 52, i.e. astring, wire or cable, is connected to the core 48 at one end thereofand extends through the helical spring 50. A hydraulic motor in the formof a cylinder/piston unit 54 is adapted to pull the flexible pullingmember 52 to contract the helical spring 50 against an arresting member56, which is fixed relative to the core 48. A tube 58 hinged to thearresting member 56 extends between the cylinder/piston unit 54 and thearresting member 56, the flexible pulling member 52 running through thetube 58 and being connected to the piston of the cylinder/piston unit54. FIG. 8 shows a similar embodiment in which a hydraulic transmissionconduit 59 is provided between two piston-cylinder assemblies 54, foruse as the hydraulic motor/device in FIG. 7.

FIG. 9 shows an embodiment of the invention in which the restrictionmember comprises two elongated helical springs 60 and 62 having freeends, and a body 64 to which the springs 60,62 are nonrotatably securedat their opposite ends. The body 64 comprises two separate parts securedto opposite end portions of the enclosing elastic hose 8 and is designedwith a releasable and lockable joint between the separate parts. Anadjustment device in the form of a drive shaft 66 has two opposite endportions connected to the helical springs 60,62, respectively, at theirfree ends. The coils of the springs 60,62 form left and right handhelices, respectively. A motor 68 is adapted to rotate the drive shaft66 in one direction to enlarge the coils of the helical springs 60,62 tolongitudinally contract the springs 60,62 and to rotate the drive shaft66 in the opposite direction to reduce the size of the coils of thesprings 60,62 to longitudinally extend the springs 60,62. Thus, theelongated helical springs 60,62 defines a restriction opening, the sizeof which is increased when the springs 60,62 are extended and decreasedwhen the springs 60,62 are contracted.

FIG. 10 shows an embodiment according to the invention which isidentical to the embodiment of FIG. 9, except that the adjustment devicecomprises a gearing having an input shaft 72 and two opposite alignedoutput shafts 74 and 76 connected to the helical springs 60 and 62,respectively, at their free ends. The input shaft 72 is connected to theoutput shafts 74,76 such that they rotate at opposite directions uponrotation of the input shaft 72. The coils of the springs 60, 62 form thesame helices.

FIGS. 11-14 show an embodiment of the device of the invention in which ahydraulic motor comprises two interconnected cylinders 78 and 80 and twopistons 82 and 84 in the respective cylinders 78,80. The cylinders 78,80have a common fluid supply inlet member 86, which together with thecylinders 78,80 takes the shape of a Y-pipe. The restriction membercomprises an elongated resilient arcuate core 88. The adjustment devicecomprises two bars 90 and 92 secured to opposite ends of the core 88 andconnected to the pistons 82 and 84, respectively. The core 88 defines arestriction opening and is provided with a releasable and lockable joint94 (FIG. 13) to permit application of the core 88 around the tissue. Thecore 88 and the cylinders 90,92 are enclosed by a soft elastic hose 96except at the joint 94 and the inlet member 86. The hose 96 has an outertubular wall 98 and a central coaxial inner tubular wall 100, which isfixed to the outer wall 98 by spoke members 102 (FIG. 14). The core 88is loosely fit in the inner tubular wall 100. By supplying fluid to orwithdrawing fluid from the inlet 86 the pistons 82 and 84 will movetowards or from each other, so that the restriction opening defined bythe core 88 is changed by the longitudinal displacement of the bars90,92.

FIGS. 15-17 show an embodiment of the invention which is identical tothe embodiment of FIGS. 11-14, except that the adjustment devicecomprises an elongated voltage responsive element 104 secured to theopposite ends of the core 88, so that the core 88 and the element 104form the restriction member. The element 104 is capable of bendinginwardly into a bow in response to a voltage applied across the element104. The radius of curvature of said bow is adjustable by changing thelevel of the voltage applied to element 104.

FIG. 18 shows an embodiment of the invention comprising a loop formingmeans in the form of a substantially rigid outer circular element 106with a releasable and lockable joint 108. In this embodiment therestriction member comprises an elastic inner circular element 110formed by the innermost wall portion of an elastic hose 112 extendingalong the outer element 106. The inner circular element 110 is disposedconcentrically within the outer circular element 106. The adjustmentdevice comprises a plurality of threads 114 secured to the elastic innerelement 110 along the circumference thereof and running from the innerelement 110 via guide members 116 attached to the outer element 106. Bypulling all the threads 114 the inner elastic element 110 is pulledunder expansion radially outwardly towards the outer element 106.

FIG. 19 shows an embodiment which is identical to the embodiment of FIG.9, except that it comprises a loop forming means in the form of asubstantially rigid outer circular element 118 supporting the helicalsprings 60,62, and a soft elastic inner wall 120 extending along thesprings 60,62. When the motor 68 rotates the helical springs 60, 62 in adirection that enlarges the coils of the springs 60,62, the coils areforced by the rigid outer element 118 to expand radially inwardlythereby reducing the size of the restriction opening formed by thecircumferential confinement surface of the restriction member (springs60,62 and body 64).

FIG. 20 shows an embodiment of the invention in which a restrictionmember comprises a plurality of arcuate lamellae 122 arranged like theconventional adjustable aperture mechanism of a camera. The adjustmentdevice, not shown, is conventional and is operated by a motor 124 toadjust the lamellae 122 to change the size of an restriction openingdefined by the lamellae 122.

FIGS. 21-23 show an embodiment of the invention in which a restrictionmember comprises two semi-circular elements 126 and 128 which are hingedtogether such that the semi-circular elements 126,128 are swingablerelative to each other between a fully open state in which theysubstantially form a circle, illustrated in FIG. 22 and an angularstate, in which the size of the restriction opening defined by thesemi-circular elements 126,128 is reduced, illustrated in FIG. 23. Theadjustment device, not shown, is conventional and is operated by a motor130 to swing the semi-circular elements 126,128 relative to each other.

FIGS. 24-27 show an embodiment of the invention in which a restrictionmember comprises an elastic belt 130 forming a circle and having asubstantially oval cross-section. The restriction member 130 is providedwith a releasable and lockable joint 132. An elastic double walled hose134 encloses the belt 130 except at the joint 132. The adjustmentdevice, not shown, is conventional and is operated by a motor 136 toturn the belt 130 around the longitudinal extension thereof between afully open state, in which the inner broader side of the belt 130 formsa substantially cylindrical surface, illustrated in FIG. 26, and areduced open state, in which the inner broader side of the belt 130forms a substantially conical surface, illustrated in FIG. 27.

FIG. 28 schematically illustrates a cushion arrangement for protectingthe penile tissue, comprising a plurality of cushions 138 disposed inseries along a substantially circular holding member 140. This cushionarrangement may be utilized in any of the above described embodiments ofthe invention.

FIGS. 29A-D provide a block diagram of four different hydraulictransmission configurations. FIG. 29A shows an adjustment device 202, aseparate reservoir 204, a one way pump 206 and an alternate valve 208.FIG. 29B shows the adjustment device 202 and an adjustable reservoir210. FIG. 29C shows the adjustment device 202, a two-way pump 212 andthe reservoir 204. FIG. 29D shows a reverse servo system with a firstclosed system controlling a second system. The servo system comprises anadjustable servo reservoir 210 and a passive adjustable fluid supplyreservoir 214. Any of the reservoirs can be the active reservoir, eitherthe servo reservoir 210 or the fluid supply reservoir 214. The reservoir214 controls a larger adjustable reservoir 216, which is used for theoperation of the adjustment device 202 for changing the restrictionopening of the restriction member.

FIGS. 30A-D are cross-sectional views of a pump mechanism adapted topump fluid in both directions only by mechanically pushing a separatesealing wall portion 218 in one direction. FIG. 30A shows a piston 220pushed forwards against a spring 222 towards the wall portion 218 andlocated in a pump housing 224 conducting fluid from a right upper fluidpassage 226 of the housing 224 to a left fluid passage 228 of thehousing 224. A main valve 230 is open and a nonreturn valve 232 isclosed. FIG. 30B illustrates the first pump movement in which the piston220 has moved forwards and reaches the wall portion 218. FIG. 30Cillustrates how the piston 220 moves backwards by the action of thespring 222. The main valve 230 is now closed and the nonreturn valve 232is open for fluid from the right upper passage 226. FIG. 30D illustrateshow the piston 220 is moved further downwards from its positionaccording to FIG. 30B while pushing the wall portion 218 downwardsagainst a second spring 234 that is stronger than spring 222, so thatfluid escapes from a right lower fluid passage 236. When moving thepiston 220 backwards from the position of FIG. 30D, fluid enters theleft fluid passage 228 and a valve 238 in the lower right fluid passage236 closes.

FIG. 31 is a cross-sectional view of a reservoir 240 defining a chamber242, the size of which is variable and is controlled by a remotecontrolled motor 244, in accordance with FIG. 29B or 29D. The reservoir240 and the motor 244 are placed in a housing 246. The chamber 242 isvaried by moving a large wall 248. The wall 248 is secured to a nut 250,which is threaded on a rotatable spindle 252. The spindle 252 is rotatedby the motor 244 via an angular gearing, which comprises two conicalgear wheels 254 and 256 in mesh with each other. The motor 244 ispowered by a battery 258 placed in the housing 246. A signal receiver260 for controlling the motor 244 is also placed in the housing 246.Alternatively, the battery 258 and the signal receiver 260 may bemounted in a separate place. The signal receiver may comprise any knownor conventional device which is capable of receiving a control signaland then operating the motor 244.

FIG. 32 is a cross-sectional view of a reservoir 262 defining a chamber264, the size of which is variable and is controlled by manualmanipulation. A gable wall portion 266 of an open ended innercylindrical housing 68 is adapted to be pushed downwards to fit in adesired locking groove 270 of a plurality of locking grooves 270 on themantle wall of the cylindrical housing 268, to reduce the size of thechamber 64. The inner cylindrical housing 268 is suspended by springs272 and is telescopically applied on an outer cylindrical housing 274.When pushing the inner cylindrical housing 268 it moves downwardsrelative to the outer cylindrical housing 274 causing the gable wallportion 266 to release from the locking groove 270 and move upwardsrelative to the inner cylindrical housing 268. When the inner housing268 is moved upwardly by the action of the springs 272 the size of thechamber 264 is increased.

FIGS. 33A and 33B show a reverse servo means comprising a mainring-shaped fluid reservoir 276 defining a chamber 278, the size ofwhich is variable. Centrally positioned in the main ring-shapedreservoir 276 there is a servo fluid reservoir 280 defining a chamber282, the size of which is variable. The chamber 282 of the servoreservoir 280 is significantly smaller than the chamber 278 of the mainreservoir 276. The two reservoirs 276 and 280 are situated between twoopposite separate walls 284 and 286, and are secured thereto. Whenchanging the amount of fluid in the servo reservoir 280, the twoopposite walls 284,286 are moved towards or away from each other,whereby the size of the chamber 278 of the main reservoir 276 ischanged.

FIG. 34 shows the basic parts of a remote control system of theapparatus of the invention including a motor, for instance the electricmotor 22. In this case, the remote control system is based on thetransmission of an electromagnetic wave signal, often of a highfrequency in the order of 100 kHz-1 gHz, through the skin 330 of thepatient. In FIG. 34, all parts placed to the left of the skin 330 arelocated outside the patient's body and all parts placed to the right ofthe skin 330 are implanted in the patient's body.

An external signal transmitting antenna 332 is to be positioned close toa signal receiving antenna 334 implanted in the patient's body close tothe skin 330. As an alternative, the receiving antenna 334 may be placedfor example inside the abdomen of the patient. The receiving antenna 334comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter,wound with a very thin wire and tuned with a capacitor to a specifichigh frequency. A small coil is chosen if it is to be implanted underthe skin of the patient and a large coil is chosen if it is to beimplanted in the abdomen of the patient. The transmitting antenna 332comprises a coil having about the same size as the coil of the receivingantenna 334 but wound with a thick wire that can handle the largercurrents that is necessary. The coil of the transmitting antenna 332 istuned to the same specific high frequency as the coil of the receivingantenna 334.

An external control unit 336 comprises a microprocessor, a highfrequency electromagnetic signal generator and a power amplifier. Themicroprocessor of the control unit 336 is adapted to switch on/off thegenerator and to modulate signals generated by the generator to senddigital information via the power amplifier and the antennas 332,334 toan implanted control unit 338. To avoid that accidental random highfrequency fields trigger control commands, digital signal codes areused. A keypad placed on the external control unit 336 is connected tothe microprocessor thereof. The keypad is used to order themicroprocessor to send a digital signal to either increase or decreasethe size of the restriction opening defined by the loop of therestriction member (e.g. as described above). The microprocessor startsa command by applying a high frequency signal on the antenna 332. Aftera short time, when the signal has energised the implanted parts of thecontrol system, commands are sent to increase or decrease the size ofthe restriction opening of the restriction member in predefined steps.The commands are sent as digital packets in the form illustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. 30 seconds or more). When a new increase or decrease step isdesired the Count byte is increased by one to allow the implantedcontrol unit 338 to decode and understand that another step is demandedby the external control unit 336. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 340, an implanted energiser unit 326 draws energy fromthe high frequency electromagnetic wave signal received by the receivingantenna 334. The energiser unit 326 stores the energy in a power supply,such as a large capacitor, powers the control unit 338 and powers theelectric motor 22 via a line 342.

The control unit 338 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 336. The microprocessor of the control unit 338 receives thedigital packet, decodes it and, provided that the power supply of theenergiser unit 326 has sufficient energy stored, sends a signal via asignal line 344 to the motor 22 to either increase or decrease the sizeof the restriction opening of the restriction member depending on thereceived command code.

Alternatively, the energy stored in the power supply of the energiserunit may only be used for powering a switch, and the energy for poweringthe motor 22 may be obtained from another implanted power source ofrelatively high capacity, for example a battery. In this case the switchis adapted to connect the battery to the control unit 338 in an “on”mode when said switch is powered by said power supply and to keep saidbattery disconnected from the control unit in a “standby” mode when theswitch is not powered.

With reference to FIG. 35, the remote control system schematicallydescribed above will now be described in accordance with a more detailedembodiment. The external control unit 336 comprises a microprocessor346, a signal generator 348 and a power amplifier 350 connected thereto.The microprocessor 346 is adapted to switch the signal generator 348on/off and to modulate signals generated by the signal generator 348with digital commands that are sent to implanted components of thedevice of the invention. The power amplifier 350 amplifies the signalsand sends them to the external signal transmitting antenna 332. Theantenna 332 is connected in parallel with a capacitor 352 to form aresonant circuit tuned to the frequency generated by the signalgenerator 348.

The implanted signal receiving antenna coil 334 forms together with acapacitor 354 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 332. The signal receiving antenna coil 334induces a current from the received high frequency electromagnetic wavesand a rectifying diode 360 rectifies the induced current, which chargesa storage capacitor 358. A coil 356 connected between the antenna coil334 and the diode 360 prevents the capacitor 358 and the diode 360 fromloading the circuit of the signal receiving antenna 334 at higherfrequencies. Thus, the coil 356 makes it possible to charge thecapacitor 358 and to transmit digital information using amplitudemodulation.

A capacitor 362 and a resistor 364 connected in parallel and a diode 366forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 368 connected in series with aresistor 370 connected in series with a capacitor 372 connected inseries with the resistor 368 via ground, and a capacitor 374, oneterminal of which is connected between the resistors 368,370 and theother terminal of which is connected between the diode 366 and thecircuit formed by the capacitor 362 and resistor 364. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 376 thatdecodes the digital information and controls the motor 22 via anH-bridge 378 comprising transistors 380,382,384 and 386. The motor 22can be driven in two opposite directions by the H-bridge 378.

The microprocessor 376 also monitors the amount of stored energy in thestorage capacitor 358. Before sending signals to activate the motor 22,the microprocessor 376 checks whether the energy stored in the storagecapacitor 358 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 376 waits for the receivedsignals to charge the storage capacitor 358 before activating the motor22.

FIGS. 36A and 36B show an embodiment of the apparatus of the inventioncomprising a restriction device 402 having an elongated flexiblerestriction member 404, such as a belt, a cord or the like. The flexiblemember 404 extends in a loop around the tissue, suitably an exit veinfrom the penis. (Alternatively, the flexible member 404 may comprise twoseparate parts on opposite sides of the vein.) One portion 404A ofmember 404 is attached to a frame 408 and another portion 404B of member404 opposite portion 404A in the loop of the flexible member 404 isconnected to an adjustment device 410, which is fixed to the frame 408.The adjustment device 410 pulls the flexible member 404 in the directionfrom portion 404A to squeeze the vein between two opposite lengths ofthe flexible member 404 to thereby restrict the blood flow in the vein406, see FIG. 36A, and releases the vein from the flexible member 404 tothereby increase the blood flow in the vein 406, see FIG. 36B.

FIGS. 37A and 37B show an embodiment of the apparatus of the inventioncomprising a restriction device 412 having two rigid plate or barelements 414 on opposite sides of the vein 406. An adjustment device 416moves the rigid elements 412 in parallel towards each other to squeezethe vein 406 between the rigid elements 412 to thereby restrict theblood flow in the vein 406, see FIG. 37A, and moves the rigid elements412 away from each other to release the vein 406, see FIG. 37B.

FIG. 38 shows an embodiment of the apparatus of the invention comprisinga restriction device 418 having two rigid articulated clamping elements420 positioned on opposite sides of the vein 406. An adjustment device422 turns the clamping elements 420 toward each other to clamp the vein406 between the clamping elements 420 to thereby restrict the blood flowin the vein 406, and turns the clamping elements 420 away from eachother to release the vein 406 from the clamping elements 420 to therebyincrease the blood flow in the vein 406.

FIGS. 39A, 39B and 39C show an embodiment of the apparatus of theinvention comprising a restriction device 424 having three bendingmembers in the form of cylindrical rollers 426, 428 and 430 displacedrelative one another in a row along the vein 406 and positionedalternately on opposite sides of the vein 406. (Alternatively, eachroller 426, 428 and 430 may take the shape of an hour-glass.) Anadjustment device 432 moves the two outer rollers 426,430 laterallyagainst the vein 406 in one direction and the intermediate roller 428against the vein 406 in the opposite direction to bend the vein tothereby restrict the blood flow in the vein 406, see FIG. 39B. Toincrease or restore the blood flow in the vein 406, the adjustmentdevice 432 moves the rollers 426-430 away from the vein 406 to releasethe vein from the rollers 426-430, see FIG. 39C.

FIGS. 40A through 44B schematically illustrates modifications of theabove embodiment according to FIGS. 39A-39C. Thus, FIGS. 40A and 40Bshow an embodiment similar to that of FIGS. 39A-39C except that thebending members are oval and not rotatable. FIGS. 41A and 41B show anembodiment similar to that of FIGS. 40A and 40B except that the ovalbending members are rotatable to release the vein, see FIG. 41A, andsqueeze the vein, see FIG. 41B. FIGS. 42A and 42B show an embodimentsimilar to that of FIGS. 39A-39C except that the intermediate roller hasa changeable diameter to release the vein, see FIG. 42A, and squeeze thevein, see FIG. 42B. FIGS. 43A and 43B show an embodiment similar to thatof FIGS. 37A-37C except that the rigid elements are replaced by twocylindrical rollers positioned on opposite sides of the vein. Finally,FIGS. 44A and 44B show an embodiment substantially similar to that ofFIGS. 43A and 43B except that the restriction device is curved to forman S-shaped curvature of the vein.

FIG. 45 schematically illustrates how any of the above-describedembodiments of the male sexual impotence treatment apparatus of theinvention may be implanted in a patient. Thus, the apparatus comprisesan adjustable restriction device 434 extending around the corpuscavernosum of the patient and a motor operated adjustment device 436 formechanically adjusting the restriction device 434 to squeeze the corpuscavernosum to thereby restrict the blood flow leaving the penis. Themotor, not shown, is integrated in the adjustment device 436 and isreversible to operate the adjustment device 436 to release the corpuscavernosum from the restriction device 434. A wireless remote control ofthe apparatus comprises an external signal transmitter 438 incorporatedin a portable remote-control case and an implanted signal receiver 440,which comprises a control unit for controlling the adjustment device 436in response to a control signal, for example an electromagnetic wavesignal, from the transmitter 438. The signal receiver 440 furthercomprises an energiser unit which transfers energy from the controlsignal transmitted by the transmitter 438 into electric energy forenergy consuming implanted components of the apparatus, such as themotor for operating the adjustment device 436. The electric energy isconducted via an implanted conductor 442 from the signal receiver 440 tothe motor. When the patient wishes to achieve erection, he readily usesthe portable remote-control case to activate the implanted adjustmentdevice 436 to temporarily adjust the implanted restriction device 434 torestrict the blood flow leaving his penis.

FIG. 46 shows an embodiment which is identical to the embodiment of FIG.45, except that the restriction device comprises two restriction members444 and 446 extending around respective exit veins from the penis. Amotor operated adjustment device, not shown, is incorporated in eachrestriction member 444,446.

There are a number of other conceivable alternative embodiments of theinvention that give the same result as the above-described embodiments.For example, the microprocessor of the external and implanted,respectively, control unit may be replaced by discrete components. Thepower amplifier of the external control unit may be omitted if thesignals generated by the signal generator are strong enough. Thereforethe invention is to be accorded the broadest interpretation of theappended claims to encompass all equivalent structures and assemblies.

The invention claimed is:
 1. A male sexual impotence treatment apparatuscomprising: an adjustable restriction device implantable in a maleimpotent patient for directly engaging a portion of the normal peniletissue or the prolongation thereof of the patient to temporarilycontract said portion of the normal penile tissue or the prolongationthereof to restrict the blood flow leaving the penis, when the patientdesires to achieve erection; an operation device for operating therestriction device; an energy transmission device for wirelesstransmission of energy from outside the patient's body to inside thepatient's body for use in connection with the operation of therestriction device including powering the operation device, wherein theoperation device comprises: (i) a motor implantable in the patient,wherein the energy transmitted by the energy transmission device (10) isused for powering the motor, which operates the restriction device; or(ii) a pump implantable in the patient, wherein the energy transmittedby the energy transmission device is used for powering the pump tooperate the restriction device to change restriction of the exit bloodflow passageway; and wherein the apparatus further comprises electricalcomponents including at least one implantable voltage level guard.
 2. Anapparatus according to claim 1, wherein the restriction device isoperable to contract said portion of the patient's penile tissue or theprolongation thereof, when the patient desires to achieve erection, suchthat the penile arterial blood flow is at least substantiallyunrestricted, whereas the penile venous blood flow is substantiallyrestricted.
 3. An apparatus according to claim 1, wherein therestriction device is designed for engagement with both of the corporacavernosa or crura of the penis or the prolongations thereof as a singleunit, or for engagement with each of the two corpora cavernosa or cruraor the prolongation thereof as two separate units.
 4. An apparatusaccording to claim 1, wherein said portion of the penile tissuecomprises one or more of the exit veins from the penis.
 5. An apparatusaccording to claim 4, wherein the restriction device is adapted tocontrol the cross-sectional area of a blood flow passageway formed bythe patient's penile exit veins.
 6. An apparatus according to claim 5,wherein the restriction device is operable to open and close the bloodflow passageway.
 7. An apparatus according to claim 6, wherein therestriction device is adapted to steplessly control the cross-sectionalarea of the blood flow passageway.
 8. An apparatus according to claim 1,comprising an adjustment device adapted to adjust the restrictiondevice.
 9. An apparatus according to claim 8, wherein the adjustmentdevice is powered.
 10. An apparatus according to claim 8, wherein theadjustment device is adapted to adjust the restriction device in anon-manual manner.
 11. An apparatus according to claim 8, wherein theoperation device operates the adjustment device.
 12. An apparatusaccording to claim 11, wherein the restriction device comprises anelement to be placed on one side of said portion of the penile tissue,and the adjustment device is adapted to squeeze said portion of thepenile tissue between the element and the human bone or tissue todecrease the blood flow leaving the penis.
 13. An apparatus according toclaim 11, wherein the restriction device comprises at least oneelongated restriction member and forming means for forming therestriction member into at least a substantially closed loop around saidportion of the penile tissue, the loop defining a restriction opening,whereby the adjustment device is adapted to adjust the restrictionmember in the loop to change the size of the restriction opening.
 14. Anapparatus according to claim 13, wherein the restriction devicecomprises several elongated restriction members to be formed into atleast substantially closed loops around the penile tissue.
 15. Anapparatus according to claim 13, wherein, the adjustment device) isadapted to adjust the longitudinal extension of the elongatedrestriction member in said loop to change the size of the restrictionopening.
 16. An apparatus according to claim 15, wherein the restrictionmember comprises a main portion and two elongated end portions and theadjustment device is adapted to establish longitudinal relativedisplacement between the end portions of the restriction member, suchthat the size of the restriction opening (is adjusted.
 17. An apparatusaccording to claim 16, wherein the adjustment device ( ) comprises amovement transferring member) in engagement with at least one of the endportions of the restriction member and operable to displace said one endportion relative to the other end portion of the restriction member. 18.An apparatus according to claim 17, further comprising a motor which isfixed relative to the main portion of the restriction member and has arotating drive shaft operatively connected to the movement transferringmember.
 19. An apparatus according to claim 18, wherein the motor ispositioned relative to the elongated restriction member such that thedrive shaft extends in parallel with a chord in said loop of therestriction member.
 20. An apparatus according to claim 15, wherein theelongated restriction member (is longitudinally resilient and theadjustment device comprises a contraction means adapted tolongitudinally contract the resilient restriction member.
 21. Anapparatus according to claim 20, wherein the elongated restrictionmember comprises a substantially non-resilient main portion and an endportion forming an elongated helical spring, which is contractible bythe contraction means.
 22. An apparatus according to claim 21, whereinthe contraction means comprises an elongated flexible pulling memberconnected to the main portion of the restriction member and extendingthrough the helical spring to contract the helical spring against anarresting member, which is fixed relative to the main portion of therestriction member.
 23. An apparatus according to claim 13, wherein therestriction member comprises an elongated helical spring having a freeend, and a body to which said spring is nonrotatably secured at itsopposite end, the adjustment device being adapted to rotate the helicalspring in one direction to enlarge the coils of the helical spring tolongitudinally contract the elongated helical spring and to rotate thehelical spring in the opposite direction to reduce the size of the coilsof the helical spring to longitudinally extend the helical spring. 24.An apparatus according to claim 23, wherein the restriction membercomprises a further elongated helical spring having a free end andnonrotatably secured to the body at its opposite end, and the adjustmentdevice comprises a drive shaft having two opposite end portionsconnected to the helical springs, respectively, at their free ends, thehelical coils forming left and right hand helices, respectively.
 25. Anapparatus according to claim 24, wherein the restriction membercomprises a further elongated helical spring having a free end andnonrotatably secured to the body at its opposite end, and the adjustmentdevice comprises a gearing having an input shaft and two oppositealigned output shafts (74,76) connected to the helical springs (60,62),respectively, at their free ends, the input shaft being connected to theoutput shafts such that the output shafts rotate in the oppositedirections upon rotation of the input shaft, the helical coils formingthe same helices.
 26. An apparatus according to claim 13, wherein therestriction member forms a radial innermost circumferential confinementsurface in said loop of the restriction member, and the adjustmentdevice is adapted to mechanically adjust the restriction member suchthat at least a portion of the confinement surface is substantiallyradially displaced in said loop.
 27. An apparatus according to claim 26,wherein the adjustment device comprises an elongated voltage responsiveelement (forming part of the confinement surface and capable of bendinginto a bow in response to a voltage applied across the element, theradius of curvature of said bow being adjustable by changing the levelof the voltage.
 28. An apparatus according to claim 26, wherein therestriction member comprises an elastic annular element forming theconfinement surface, and the adjustment device is adapted to change thediameter of the elastic annular element.
 29. An apparatus according toclaim 26, wherein the forming means comprises a substantially rigidouter annular element, and the restriction member comprises an elongatedhelical spring extending internally along the outer annular element andcontacting the latter, the helical spring forming part of thecircumferential confinement surface and having a free end, and a body towhich the helical spring is nonrotatably secured at its opposite end,the adjustment device being adapted to rotate the helical spring in onedirection to enlarge the coils of the helical spring to contract thecircumferential confinement surface and to rotate the helical spring inthe opposite direction to reduce the size of the coils of the helicalspring to expand the circumferential confinement surface.
 30. Anapparatus according to claim 26, wherein the forming means comprises asubstantially rigid outer annular element, and the restriction membercomprises a first and a second elongated helical spring extendinginternally along the outer annular element and contacting the latter,the helical springs forming part of the circumferential confinementsurface, the first and the second spring, respectively, having a freeend, and a body to which the first and the second spring, respectively,is nonrotatably secured at its opposite end, the adjustment device beingadapted to rotate the first and the second spring, respectively, in onedirection to enlarge the coils of the spring to contract thecircumferential confinement surface and to rotate the first and thesecond spring, respectively, in the opposite direction to reduce thesize of the coils of the spring to expand the circumferentialconfinement surface.
 31. An apparatus according to claim 13, wherein therestriction member comprises at least two separate elements, at leastone of which is pivoted such that it is turnable in a plane in whichsaid loop of the restriction member extends, and the adjustment deviceis adapted to turn said pivoted element to change the size of saidrestriction opening.
 32. An apparatus according to claim 13, wherein theelongated restriction member is elastic and varies in thickness as seenin a cross-section thereof, and the adjustment device is adapted to turnthe restriction member around the longitudinal extension thereof.
 33. Anapparatus according to claim 13, wherein the forming means comprises aspring material forming the elongated restriction member into the loop,such that the restriction opening has a predetermined size, and theadjustment device is adapted to adjust the restriction member againstthe spring action of the spring material.
 34. An apparatus according toclaim 33, wherein the spring material is integrated in the restrictionmember.
 35. An apparatus according to claim 13, wherein the formingmeans is adapted to form the restriction member into a loop having apredetermined size or a size selected from several predetermined sizes.36. An apparatus according to claim 13, wherein the adjustment device isadapted to change the size of the restriction opening such that theouter circumferential confinement surface of the restriction member ischanged.
 37. An apparatus according to claim 13, wherein the adjustmentdevice is adapted to change the size of the restriction opening suchthat the outer circumferential confinement surface of the restrictionmember is unchanged.
 38. An apparatus according to claim 13, wherein theelongated restriction member is flexible, and the adjustment device isadapted to pull a first portion of the flexible restriction member froma second portion of the flexible restriction member opposite the firstportion in the loop to squeeze said portion of the penile tissue betweentwo opposite lengths of the elongated flexible restriction member torestrict the blood flow leaving the penis, and to release said portionof the penile tissue from the flexible restriction member to increasethe blood flow leaving the penis.
 39. An apparatus according to claim11, wherein the restriction device comprises at least two elements to beplaced on different sides of said portion of the penile tissue, and theadjustment device is adapted to squeeze said portion of the peniletissue (406) between the elements to restrict the blood flow leaving thepenis, and to release said portion of the penile tissue (406) from theelements to increase the blood flow leaving the penis.
 40. An apparatusaccording to claim 11 wherein the restriction device comprises at leasttwo articulated clamping elements to be positioned on opposite ordifferent sides of said portion of the penile tissue, and the adjustmentdevice is adapted to turn the clamping elements toward each other toclamp said portion of the penile tissue between the clamping elements torestrict the blood flow leaving the penis, and to turn the clampingelements away from each other to release said portion of the peniletissue from the clamping elements to increase the blood flow leaving thepenis.
 41. An apparatus according to claim 11, wherein the restrictiondevice is adapted to bend a portion of said portion of the peniletissue.
 42. An apparatus according to claim 41, wherein the restrictiondevice (comprises at least two bending members to be positioned onopposite or different sides of said portion of the penile tissue and tobe displaced relative to each other along the penile tissue, and theadjustment device is adapted to move the bending members against saidportion of the penile tissue to bend it to restrict the blood flowleaving the penis, and to move the bending members away from saidportion of the penile tissue to release it from the bending members toincrease the blood flow leaving the penis.
 43. An apparatus according toclaim 42, wherein the bending members comprise rollers.
 44. An apparatusaccording to claim 11, wherein the restriction device is adapted torotate a portion of the penile tissue.
 45. An apparatus according toclaim 11, the motor is operatively connected to the adjustment device.46. An apparatus according to claim 45, wherein the operation devicecomprises a reverse servo connected between the motor and the adjustmentdevice.
 47. An apparatus according to claim 45, comprising animplantable reversing device for reversing the motor.
 48. An apparatusaccording to claim 45, wherein the motor is fixed to the restrictiondevice.
 49. An apparatus according to claim 45, wherein the motor isremote from the restriction device and is connected to the adjustmentdevice by a power transmission conduit.
 50. An apparatus according toclaim 11, wherein the operation device comprises a servo meanstransferring weak force acting on a moving element having a long strokeinto strong force acting on an element with a short stroke.
 51. Anapparatus according to claim 50, wherein the servo means comprises amotor, preferably an electric motor.
 52. An apparatus according to claim51, wherein the motor is reversible.
 53. An apparatus according to claim11, wherein the operation device comprises hydraulic means for operatingthe restriction device.
 54. An apparatus according to claim 53, furthercomprising a reservoir containing a predetermined amount of fluid forsupplying the hydraulic means with fluid.
 55. An apparatus according toclaim 54, wherein the reservoir defines a chamber for the predeterminedamount of fluid and the hydraulic means is adapted to change the volumeof the chamber.
 56. An apparatus according to claim 54, wherein a pumpis adapted to pump fluid between the reservoir and the adjustmentdevice.
 57. An apparatus according to claim 54, wherein the hydraulicmeans comprises a reverse servo) transferring a strong force acting on amoving element with a short stroke into a weak force acting on movingelement with a long stroke.
 58. An apparatus according to claim 57,wherein the reverse servo is manually operated.
 59. An apparatusaccording to claim 57, wherein the reverse servo is powered.
 60. Anapparatus according to claim 59, wherein the reverse servo comprises amotor, preferably an electric motor.
 61. An apparatus according to claim60, wherein the motor is reversible.
 62. An apparatus according to claim57, wherein the hydraulic means comprises first and second wall portionsof the reservoir, and the reverse servo is adapted to provide relativedisplacement between the first and second wall portions of thereservoir.
 63. An apparatus according to claim 54, wherein the hydraulicmeans of the operation device comprises a fluid conduit, the reservoirforming part of the conduit.
 64. An apparatus according to claim 63,wherein the hydraulic means including the conduit are devoid of anynon-return valve.
 65. An apparatus according to claim 53, wherein thehydraulic means is devoid of any non-return valve.
 66. An apparatusaccording to claim 1, wherein the restriction device comprises at leasttwo frame elements, which are foldable towards each other by theadjustment device.
 67. An apparatus according to claim 66, wherein thefoldable frame elements comprise two substantially semi-circular frameelements, which are hinged together such that the semicircular elementsare swingable relative to each other from a fully open state in whichthey substantially form a circle to a fully folded state in which theyform a semicircle.
 68. An apparatus according to claim 1, wherein therestriction device is non-inflatable.
 69. An apparatus according toclaim 1, further comprising a wireless remote control for non-invasivelycontrolling the restriction device.
 70. An apparatus according to claim69, wherein the remote control comprises a separate signal transmitterand/or receiver and an implantable signal receiver and/or transmitter),for transmitting and/or receiving a control signal.
 71. An apparatusaccording to claim 70, wherein the signal receiver (comprises a controlunit adapted to control the adjustment device in response to the controlsignal.
 72. An apparatus according to claim 71, further comprising animplantable energiser unit for providing energy to energy consumingcomponents of the apparatus to be implanted in the patient.
 73. Anapparatus according to claim 72, wherein the energiser unit is adaptedto transform energy from the control signal, as it is transmitted to thesignal receiver into electric energy.
 74. An apparatus according toclaim 73, wherein the implantable motor is an electrical motor thatoperates the adjustment device, and wherein the energiser unit comprisesa rechargeable electric power supply for storing the electric energy andthe control unit is adapted to power the electric motor with energy fromthe rechargeable electric power supply in response to the controlsignal.
 75. An apparatus according to claim 72, wherein the energiserunit (is adapted to transform energy from the control signal into adirect or alternating current.
 76. An apparatus according to claim 72,wherein the energiser unit comprises a battery, an electrically operableswitch adapted to connect the battery to the signal receiver in an “on”mode when the switch is powered and to keep the battery disconnectedfrom the signal receiver in a “standby” mode when the switch is notpowered, and a rechargeable electric power supply for powering theswitch.
 77. An apparatus according to claim 76, wherein the control unitis adapted to power the electric motor with energy from the battery inresponse to a control signal received from the signal transmitter, whenthe switch is in its “on” mode.
 78. An apparatus according to claim 72,wherein the energiser unit comprises a battery and a switch operable bythe wireless energy transmitted by the energy transmission device, forconnecting the battery to the signal receiver in an “on” mode when theswitch is powered by the wireless energy and to keep the batterydisconnected from the signal receiver in a “standby” mode when theswitch is not powered.
 79. An apparatus according to claim 78, whereinthe energy transmission device is adapted to directly power the switchwith the wireless energy to switch into the “on” mode.
 80. An apparatusaccording to claim 69, wherein the implantable motor operates theadjustment device.
 81. An apparatus according to claim 80, wherein thecontrol unit is adapted to control the energiser unit to power the motorwith energy in response to the control signal.
 82. An apparatusaccording to claim 80, wherein the motor is an electric motor.
 83. Anapparatus according to claim 69, wherein the remote control is capableof obtaining information from implantable components of the apparatusand of commanding the adjustment device to adjust the restriction devicein response to obtained information.
 84. An apparatus according to claim1, further comprising an implantable energiser unit for providing energyto energy consuming components of the apparatus to be implanted in thepatient.
 85. An apparatus according to claim 84, wherein the energiserunit is adapted to transform the wireless energy into electric energy.86. An apparatus according to claim 85, the implantable motor is anelectric motor that operates adjustment device, wherein the energiserunit is adapted to power the electric motor with the electric energytransformed from the wireless energy.
 87. An apparatus according toclaim 85, wherein the energiser unit comprises an implantableaccumulator or battery, and the electric energy is adapted to charge theaccumulator or battery.
 88. An apparatus according to claim 87, whereinthe energy transforming device comprises a capacitor.
 89. An apparatusaccording to claim 84, wherein the energiser unit comprises a batteryand a switch operable by the wireless energy transmitted by the energytransmission device, for connecting the battery to the implantableenergy consuming components of the apparatus in an “on” mode when theswitch is powered by the wireless energy and to keep the batterydisconnected from the energy consuming components in a “standby” modewhen the switch is not powered.
 90. An apparatus according to claim 1,comprising a single voltage level guard.
 91. An apparatus accordingclaim 90, further comprising an implantable capacitor or accumulator,wherein the charge or discharge of the capacitor or accumulator iscontrolled by use of the voltage level guard.
 92. An apparatus accordingto claim 91, wherein the capacitor has a capacity less than 0.1 μF. 93.An apparatus according to claim 1, wherein the electrical components aredevoid of any current detector and/or charge level detector.
 94. Anapparatus according to claim 1, further comprising an energy transfermeans for wireless transfer of energy from outside the patient's body tothe energy consuming implantable components of the apparatus.
 95. Anapparatus according to claim 94, wherein the energy transfer means isadapted to intermittently transfer the energy in the form of a train ofenergy pulses for direct use in connection with the energising of theenergy consuming components of the apparatus.
 96. An apparatus accordingto claim 95, wherein the energy transfer means is adapted to transferelectric energy, and further comprising an implantable capacitor forproducing the train of energy pulses.
 97. An apparatus according toclaim 94, wherein the energy transfer means is adapted to directly powerthe motor or pump with transferred energy.
 98. An apparatus according toclaim 94, wherein the energy transferred by the energy transfer meanscomprises an electric field or a magnetic field.
 99. An apparatusaccording to claim 94, wherein the energy transferred by the energytransfer means comprises a signal.
 100. An apparatus according to claim99, wherein the signal comprises analog or digital pulses.
 101. Anapparatus according to claim 100, wherein the analog or digital pulsescomprise a magnetic field or an electric field.
 102. An apparatusaccording to claim 99, wherein the signal comprises a wave signal. 103.An apparatus according to claim 102, wherein the wave signal comprisesan electromagnetic wave signal, a sound wave signal or a carrier wavesignal.
 104. An apparatus according to claim 103, wherein the carriersignal is frequency, amplitude or frequency and amplitude modulated.105. An apparatus according to claim 103, wherein the control signalcomprises a wave signal comprising one of a sound wave signal includingan ultrasound wave signal, an electromagnetic wave signal including aninfrared light signal, a visible light signal, an ultra violet lightsignal and a laser light signal, a micro wave signal, a radio wavesignal, an x-ray radiation signal, and a gamma radiation signal.
 106. Anapparatus according to claim 94, wherein the energy transforming devicecomprises a capacitor.
 107. An apparatus according to claim 106, whereinthe capacitor is adapted to produce electric pulses from the transformedelectric energy.
 108. An apparatus according to claim 94, wherein theenergy transfer means is adapted to transfer magnetic energy,non-magnetic energy, electromagnetic energy, non-electromagnetic energy,kinetic energy, non-kinetic energy, sonic energy, non-sonic energy,thermal energy or non-thermal energy.
 109. An apparatus according toclaim 1, wherein the energy transmission device is adapted to transmitwireless energy in the form of a magnetic field or electromagnetic wavesfor direct power of the motor or pump, as the wireless energy is beingtransmitted.
 110. An apparatus according to claim 109, wherein the pumpis not a plunger type of pump.
 111. An apparatus according to claim 110,wherein the energy transfer means is adapted to transfer wireless energyin the form of electromagnetic waves excluding radio waves.
 112. Anapparatus according to claim 1, further comprising a pressure sensor fordirectly or indirectly sensing the pressure against the restrictiondevice.
 113. An apparatus according to claim 112, wherein therestriction device is controlled in response to signals from thepressure sensor.
 114. An apparatus according to claim 1, furthercomprising an implantable energy transforming device for transformingwireless energy directly or indirectly into energy different than thewireless energy for operation of the restriction device.
 115. Anapparatus according to claim 114, wherein the energy transforming devicetransforms the wireless energy into kinetic energy for operation of therestriction device.
 116. An apparatus according to claim 114, whereinthe energy transforming device transforms the wireless energy in theform of sound waves into electric energy for operation of therestriction device.
 117. An apparatus according to claim 116, whereinthe energy transforming device transforms the wireless energy in theform of sound waves directly into electric energy.
 118. An apparatusaccording to claim 1, further comprising an implantable accumulator orbattery and means for controlling the accumulator or battery fromoutside the patient's body to supply energy to the adjustment deviceand/or other implantable energy consuming components of the apparatus.119. An apparatus according claim 1, wherein the restriction device isdesigned for implantation in the base of the patient's penis or itsprolongation.
 120. An apparatus according to claim 1, further comprisingan adjustment device for adjusting the restriction device to change therestriction of the blood flow passageway, wherein the adjustment deviceis adapted to mechanically adjust the restriction device, or adapted tohydraulically adjust the restriction device by using hydraulic meanswhich is devoid of hydraulic fluid of the kind having a viscosity thatsubstantially increases when exposed to heat or a magnetic field. 121.An apparatus according to claim 1, further comprising an implantablereversing device, wherein the restriction device is capable ofperforming a reversible function and the reversing device reverses thereversible function.